Status:
COMPLETED
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
Lead Sponsor:
Rania Mahmoud Mohamed
Collaborating Sponsors:
Future University in Egypt
Conditions:
Bioequivalence
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.
Detailed Description
A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteer...
Eligibility Criteria
Inclusion
- Written informed consent is obtained for study.
- Age 18 - 55 years,
- Body mass index between 18.5 and 30 kg/m2
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
- Vital signs without significant deviations.
- All laboratory screening results are within the normal range or clinically non-significant
Exclusion
- History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
- History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
- Any confirmed significant allergic reactions against any drug, or multiple allergies.
- Clinically significant illness 28 days before study phase I.
- Alcohol or any solvent intake.
- Regular use of medication.
- Positive urine screening of drugs of abuse.
- Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
- History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
- Blood donation within the past 60 days.
- Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05197517
Start Date
September 21 2020
End Date
October 1 2020
Last Update
January 20 2022
Active Locations (1)
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1
Future Research Center (FRC)
Cairo, Egypt